(120 days)
Not Found
No
The description focuses on the physical design and performance of a guide wire, with no mention of AI or ML capabilities.
No
The device is a guide wire intended to facilitate the delivery of other interventional devices and procedures, not to provide therapy itself. While it can be used during therapeutic procedures, its function is supportive rather than therapeutic.
No
Explanation: The device is a guide wire intended to facilitate the delivery of catheter-based interventional devices and distinguish vasculature, but its primary function is interventional, not diagnostic. While it can "distinguish the vasculature," which has a diagnostic component, its overall purpose is to provide a pathway for therapeutic procedures.
No
The device description clearly describes a physical guide wire, which is a hardware component used in medical procedures. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to facilitate the delivery of other interventional devices during procedures like PTCA and PTA. It's a tool for navigating and providing access within the vascular system.
- Device Description: The description details the physical construction of a guide wire, a device designed to be inserted into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health, diagnosis, or condition. IVDs are typically reagents, instruments, or systems used for testing samples in a laboratory or point-of-care setting.
This device is an interventional medical device used during surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
The HI-TORQUE PROGRESS Guide Wire (K091825, cleared Sept. 25, 2009) is an existing family of guide wires, designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires has a maximum diameter of 0.0140" with a stainless steel core and is provided in 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS guide wire family is offered in 5 configurations: PROGRESS 40. PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.
The HI-TORQUE PILOT Guide Wire (K030549/K101116, originally cleared Mav 14, 2003) is an existing family of guide wires constructed using a 304V stainless steel core. HI-TORQUE PILOT Guide Wires have a maximum diameter of 0.0140" and are available in 190cm extendable lengths and a 300 cm exchange length. There are three HI-TORQUE PILOT™ Guide Wire designs with varying tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150, and HI-TOROUE PILOT™ 200 Guide Wires). The distal segment of the guide wire includes a series of tapered grinds and a flat section, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel structure, coronary occlusions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The EXPERT CTO trial was a prospective, multi-center, single-arm study with approximately 250 subjects planned for enrollment. The initial 138 subjects had HI-TORQUE PROGRESS or HI-TORQUE PILOT guide wires used.
The primary endpoint of successful recanalization of the CTO was achieved in 79.0% (109/138) of the subjects with a lower one-sided 95% confidence interval (CI) of 72.8%. The study guide wire successfully met its endpoint as the lower one-sided 95% CI was above the protocol-specified performance goal of 62.5% (p
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
510(k) Summary - K123067
Abbott Vascular Inc.
The 510(k) Summary is submitted in accordance with 21 CFR §807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.
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- Submitter's Name
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- Submitter's Address
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- Telephone
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- Fax
,
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- Contact Person
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- Date Prepared
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- Device Trade Name(s)
(951) 914-3031
(951) 914-0339
Sean Mullin
Sept 28, 2012
Guide Wire
Hi-Torque Progress Guide Wire Family
P.O. Box 9018, Temecula, CA 92589
Hi-Torque Pilot Guide Wire Family
Catheter Guide Wire (DQX)
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Device Common Name
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Device Classification Name
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Predicate Device(s) Name(s)
HI-TORQUE PROGRESS Guide Wire (K091825, cleared Sept. 25, 2009)
HI-TORQUE PILOT Guide Wire (K030549/K101116, originally cleared May14, 2003)
1
7.1 Device Description (HI-TOROUE PROGRESS)
The HI-TOROUE PROGRESS Guide Wire (K091825, cleared Sept. 25, 2009) is an existing family of guide wires, designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires has a maximum diameter of 0.0140" with a stainless steel core and is provided in 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS guide wire family is offered in 5 configurations: PROGRESS 40. PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.
7.2 Device Description (HI-TOROUE PILOT)
The HI-TOROUE PILOT Guide Wire (K030549/K101116, originally cleared Mav 14, 2003) is an existing family of guide wires constructed using a 304V stainless steel core. HI-TORQUE PILOT Guide Wires have a maximum diameter of 0.0140" and are available in 190cm extendable lengths and a 300 cm exchange length. There are three HI-TORQUE PILOT™ Guide Wire designs with varying tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150, and HI-TOROUE PILOT™ 200 Guide Wires). The distal segment of the guide wire includes a series of tapered grinds and a flat section, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance.
7.3 Indication for Use (HI-TOROUE PROGRESS and HI-TOROUE PILOT)
Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion. provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).
7.4 Technological Characteristics
There have been no physical changes to the subject devices as compared to the currently marketed predicate devices except for a change in indication and related clinical information provided in the IFU and labeling. Comparisons of the technological characteristics such as product performance, design, and intended use between the subject and predicate devices show that they are substantially equivalent.
2
7.5 In Vitro Bench, Biocompatibility, Packaging and Sterilization Testing
There have been no physical changes to the subject devices as compared to the predicate devices except for a change in indication statement and related clinical information provided in the IFU and labeling. Comparisons of in-vitro bench, biocompatibility, packaging, and sterilization testing are not necessary. The subject and predicate devices are identical and in-vitro bench testing, biocompatibility, packaging and sterilization for the subject devices are therefore substantially equivalent to their respective predicate devices.
7.6 EXPERT CTO Guidewire Clinical Trial Summary
Objectives
The primary objectives of this trial are to:
- assess the safety and effectiveness of the HI-TORQUE (HT) PROGRESS and HT . PILOT guide wires in recanalization of chronic total occlusions and
- assess the safety and effectiveness of the MINI TREK Coronary Dilatation . Catheter in predilatation of chronic total occlusions.
- assess the safety and effectiveness of the XIENCE V, XIENCE nano, and . XIENCE PRIME Everolimus Eluting Coronary Stent Systems for the treatment of chronic total coronary occlusions.
Although the guidewire and predilatation portions of the EXPERT CTO clinical trial are complete, the longer term safety and effectiveness results of the XIENCE V and XIENCE PRIME stent systems in the treatment of chronic total occlusions is ongoine. The MINI TREK predilatation results and XIENCE V and XIENCE PRIME results will be reported separately.
Trial Design
The EXPERT CTO is a prospective, multi-center, single-arm study. Approximately 250 subjects with signs and/or symptoms considered typical of ischemic heart disease attributed to a CTO are expected to be enrolled. Subjects will undergo elective, attempted CTO percutaneous revascularization.
For the initial 138 subjects enrolled. HT PROGRESS or HT PILOT guide wires (the study guidwires) were used in each case. Other, non-study guidewires may also have been used in each case at the discretion of the physician. Successful guide wire crossing was defined as confirmation of the presence of a guide wire in the distal true lumen. Guide wire subjects were followed through hospital discharge. The target lesions were predilated using a standard angioplasty balloon. For at least the initial 60 subjects with successful guide wire crossing, identified as confirmation of the guide wire in the distal true lumen, the MINI TREK Coronary Dilatation Catheter was to be used for the first predilatation attempt. The XIENCE V and/or XIENCE PRIME stents were to be used in all subjects
3
for whom recanalization and predilatation of the target lesion was completed. Stent subjects are to be followed through 5 years with follow-up at 30 days, 6 months, 1 year, and annually thereafter through 5-years.
4
7.7 -Results
Primary Endpoint Analysis
The primary endpoint of successful recanalization of the CTO was achieved in 79.0% (109/138) of the subjects with a lower one-sided 95% confidence interval (CI) of 72.8%. The individual criteria for successful recanalization included: confirmation of placement of any guide wire in the distal true lumen in 89.9% (124/138) of the subjects and absence of in-hospital MACE (per ARC MI definition) in 89.1% (123/138) of the subjects.
Because the lower one-sided 95% Cl is above the protocol-specified performance goal of 62.5% (p